We often “preach to the choir” on the value of modeling, but training the partners and decision makers who interpret and synthesize our work into the bigger picture is absolutely critical for MIDD to have a real impact. I am incredibly proud to have been part of the development of a curriculum to train regulatory scientists, particularly clinical reviewers, in Model Informed Drug Development. I completed two lectures on the various model types commonly used for MIDD [Part 1, Part 2].
The educational series, entitled “Model-Informed Drug Development (MIDD): Methods Advancing Medical Products to Patients” was developed by experts in the field in partnership with the Critical Path Institute and funded by FDA CDER Office of Translational Sciences. This resource was recently made accessible to the public via YouTube through the FDA Quantitative Medicine Center of Excellence. There were many excellent presenters, and it was an honor to work with the distinguished scientists on the steering committee: Jeff Barrett, Klaus Romero, Craig Rayner, Marc Gastonguay, Goonaseelan (Colin) Pillai, Steven Kern, and our FDA liaisons, Qi Liu, Raj Madabushi, and Issam Zineh.
The efforts were summarized in A Modern Curriculum for Training Scientists in Model-Informed Drug Development: Progress Report on FDA Grant to Train Regulatory Scientists, published in Clinical Pharmacology and Therapeutics.
Kudos to the FDA and C-Path for making this important series open to the public to help to expand the reach of MIDD appreciation and understanding!
Figure 2 from ” A Modern Curriculum for Training Scientists in Model-Informed Drug Development: Progress Report on FDA Grant to Train Regulatory Scientists” https://ascpt.onlinelibrary.wiley.com/doi/10.1002/cpt.3039